Engage client data management during start up.
- Create protocol folder(s) for study documentation.
- Add entries into individual protocol spreadsheet.
- Review Statement of Work (SOW) for study scope.
- Ensure start-up packet delivery to clients.
- Contact clients for initial study discussion and determine authors of Data Transfer Specifications (DTS).
- Provide recommendations and alternatives to optimize data quality.
- Collaborate with clients to finalize Data Transfer Specifications (DTS).
- Obtain final client approval on Data Transfer Specifications (DTS).
Act as a data liaison between Clinical Data Management and all other Covance departments and business units.
- Consult with Medical Affairs via a Med/Tech Affairs Request Form.
- Collaborate with Project Management proactively and reactively regarding study questions.
- Manage and resolve issues with Specimen Management.
- Initiate data changes with the appropriate department and revise all non-compliant requests.
- Partner with other Covance departments and business units, and provide integrated support and process improvements as needed.
Create standard data transfer format(s) in compliance with client requests while adhering to both internal processes and regulatory standards.
- Build and modify Data Transfer formats as needed.
- Create test data if needed.
- Quality Check (QC) test files.
- Deliver test files to clients and log into the metrics tool.
- Obtain client approval and store auditable documentation.
Provide ongoing client support (study maintenance).
- Create global transmission instructions.
- Schedule appropriate frequency of data transfers.
- Address errors and client issues including queries.
- Participate in study-related meetings.
- Collaborate with clients regarding study modifications.
- Confirm changes and send files as needed.
- Maintain auditable documents.
- Facilitate Data Management functions of end-to-end data lock processes.
- Represent Clinical Data Management in client visits, audits, inspections and bid defenses as needed.
- Collaborate with clients regarding new service requests.
- Support billing of services as needed.
Attend training to increase Data Manager’s capabilities (including corporate, departmental and sponsor-related training).
Ensure uninterrupted client service.
- Support peers by sharing technical knowledge and customer service skills.
- Back up peers as needed.
Record data transfer activities and maintain protocol portfolios as required to track workload and productivity.
Other duties as assigned.
- BS/BA four-year degree or equivalent education, or 4 years Covance experience
- Strong organizational, planning and critical-thinking skills.
- Well-polished, inclusive, and engaging communication skills (written and verbal).
- Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
- Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
- Ability to use standard Microsoft suite of software products.
- Conversant with databases and database terminology.
- Strong technical aptitude.
- Customer Service experience.
- Data Management and/or Clinical Trials experience.
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